FDA Clears Sonic Incytes' Velacur® VDFF for MASLD and MASH

Sonic Incytes Medical Corp, based in Vancouver, British Columbia, has achieved a significant milestone with the U.S. Food and Drug Administration (FDA) granting 510(k) clearance for its Velacur® Determined Fat Fraction (VDFF). This advanced measurement technology, embedded within the Velacur® device software, integrates quantitative measures of ultrasound attenuation and backscatter. Notably, VDFF demonstrates a strong correlation coefficient of 0.85 with MRI proton density fat fraction (MRI-PDFF), the gold standard for liver fat quantification in hospitals. VDFF boasts an impressive accuracy of 95% in classifying patients with more than 5% MRI-PDFF, effectively diagnosing hepatic steatosis.

VDFF’s introduction is a game-changer for managing hepatic steatosis at the point of care, offering similar clinical utility to MRI-PDFF. With nearly 100 million individuals in the United States affected by metabolic dysfunction-associated steatotic liver disease (MASLD), and approximately 20% of these cases advancing to metabolic dysfunction-associated steatohepatitis (MASH), a severe chronic condition with cancer and mortality risks, the need for effective diagnostic tools at the point of care is critical. Existing non-invasive methods, particularly those available at the point-of-care, have limitations in diagnosing these conditions effectively.

The timing of VDFF's introduction aligns with the FDA’s recent approval of the first MASH therapeutic. Additionally, the American Association for the Study of Liver Diseases (AASLD) has issued new clinical guidance recommending liver ultrasound as a secondary screening tool following blood tests. The AASLD also highlighted the inadequacies of the controlled attenuation parameter (CAP) used in FibroScan devices for accurately quantifying or monitoring liver fat changes.

Dr. Naim Alkhouri, Chief Medical Officer and Chief of Transplant Hepatology at Arizona Liver Health, emphasized the urgent need for reliable non-invasive tests (NITs) in light of the approval of Rezdiffra (Madrigal Pharmaceuticals). He remarked that VDFF equips healthcare providers with essential data to manage and monitor patients effectively at the point of care.

The efficacy of VDFF is supported by clinical research published in the World Federation for Ultrasound in Medicine and Biology. Sonic Incytes plans to roll out the VDFF feature to all new and existing Velacur® users in the United States through an upcoming software update.

Sonic Incytes is dedicated to improving patient care through innovative diagnostic solutions. Its flagship product, Velacur™, provides physicians with a state-of-the-art liver imaging tool to address the increasing prevalence of fatty liver disease. Velacur offers real-time, AI-guided quantification of key markers for fatty liver disease, including liver stiffness, attenuation, and VDFF. With its real-time results, low upfront cost, and AI guidance, Velacur makes liver imaging at the point of care both affordable and accessible.

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